Surgical Sling May Prevent Incontinence

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This study found that placing a sling during surgery for vaginal prolapse helps prevent urinary incontinence, but carries a slightly higher risk of adverse events, including bladder perforation and urinary tract infection.

Note that the number needed to treat with a sling to prevent one case of urinary incontinence at 3 months was 3.9, and at 1 year was 6.3.

One year after surgery, patients who had had the sling placed during the initial procedure were about half as likely to have incontinence as those who didn't have the sling (adjusted OR 0.48, 95% CI 0.30 to 0.77, P=0.002), John Wei, MD, of the University of Michigan in Ann Arbor, and colleagues reported in the June 21 issue of the New England Journal of Medicine.

But they noted that counseling patients who will have vaginal prolapse surgery "should include attention to both the benefits and risks of sling placement."

Women who have surgery for pelvic organ prolapse are at risk for postoperative urinary incontinence, so some clinicians place a mid-urethral sling to reduce the risk, though there's little evidence about its risks and benefits.

So Wei and colleagues conducted the Outcomes Following Vaginal Prolapse Repair and Mid-urethral Sling (OPUS) trial in 337 women who were going to have vaginal prolapse surgery. They were randomized to receive either a mid-urethral sling or sham incisions during surgery.

The primary endpoint was urinary incontinence or treatment for the condition at 3 months, with a secondary primary endpoint assessment at 1 year. A total of 327 women completed follow-up at that time.

The researchers found that at 3 months, the rate of urinary incontinence was higher among those who underwent sham incisions than among those who had had the sling placed (49.4% versus 23.6%) (adjusted OR 0.31, 95% CI 0.19 to 0.50, P<0.001).

The results held at 1 year, with 43% of those in the sham group having urinary incontinence compared with 27.3% of those in the sling group (adjusted OR 0.48, 95% CI 0.30 to 0.77, P=0.002).

The number needed to treat with a sling to prevent one case of urinary incontinence at 3 months was 3.9, and at 1 year was 6.3.

During follow-up, 7.3% of women in the sling group were treated for urinary incontinence, compared with 11% of those in the sham group.

Wei and colleagues reported that 5% of those in the sham group had a sling procedure in the first year after surgery, but sling removal occurred in only 2.4% of those who had it placed during the initial surgery.

Sling placement carried some risks, though. The following complications occurred at a higher percentage in the sling group (P≤0.05 for all):

Bladder perforation (6.7% versus 0%)

Urinary tract infection (31% versus 18.3%)

Major bleeding complications (3.1% versus 0%)

Incomplete bladder emptying six weeks after surgery (3.7% versus 0%)

The study was limited because surgeons couldn't be blinded and because the findings can't be extrapolated beyond 1 year, the researchers noted.

In an accompanying editorial, Cheryl Iglesia, MD, of Georgetown University, noted that questions about placing slings during initial vaginal prolapse surgery have been fueled by recent FDA warnings about the risks associated with transvaginal mesh, as well as Johnson & Johnson's voluntary removal of its mesh products from the market.

Iglesia noted, however, that the slings are clearly different from the mesh, in that the slings are straps only about 1 cm wide with an average length of 10 cm, while the mesh sheets can span up to 10 cm wide and 20 cm long.

She wrote that the benefits of the sling likely outweigh the risks for women who have stress urinary incontinence before their surgery, but if not, then the "risk-benefit ratio is less predictable," and decisions about preventive placement "should factor in the goals and desires of the patient, the skill and experience of the surgeon, and the risks and potential benefits for a particular patient."

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH Office of Research on Women's Health.

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